The Investigations

By John McCormick  |  Posted 2004-03-08 Print this article Print

Multidatas Mick Conley, in an interview with Baseline on Feb. 19, maintained that his company first heard full details of the overdoses from the FDA and the NRC in June 2001.

But Aguirre says that is not true. His team notified Multidata in April, he says, two days after they returned from Panama to the U.S.

"We told them, Your equipment has had an accident, go and make sure that for all the systems youve sold in the world, people are aware this is a problem," Aguirre says.

The IAEA report confirms that the Houston team notified Multidata in April, "and that it was impressed upon Multidata to send someone to Panama as soon as possible to resolve this problem." But Roestel says Multidata could not get enough information from the hospital or the Houston team on exactly what had happened.

In addition, Conley says, in order for the company to send representatives to Panama, the hospital would have needed a service contract with the company, which it didnt have, although he adds that Multidata provides telephone support to anybody with its product.

But before sending a team out, Conley says, "you really have to have an idea of what the problem is." If another customer called in a similar situation, he says, Multidata would want a clear explanation of what the problem was so that they "knew what kind of person to send to a place and what kind of tools to send along with them."

On May 18, after several patients had already died, the Panamanian government announced the overdoses, and international agencies began to act. In the U.S., the NRC sent out warnings on June 1 and again on June 6 alerting hospitals licensed to perform radiation therapy of the overdoses-and that Multidatas software was involved.

Multidata issued its first warning to customers on June 22, although it did not say which versions of its software were affected or how the overdoses happened. The company directed users to "follow instructions in the user manual...follow a written quality assurance procedure...and perform verification measures."

Multidata issued what Conley calls a "voluntary in-field correction," starting in the fall of 2001. The software patch checked treatment-planning calculations and rejected anything that was not identified by the system as a valid shape. "We changed the software so that [the Panama incident] could not happen again," he says.

Conley maintains the company was initially unaware the software was still being used in Panama. "We never heard from [the hospital]," he says. Conley and Roestel also contend the software was fine and that the problem was user error.

The IAEA report did note that quick action by the hospital staff could have prevented the overdoses.

At the end of May 2001, right after the FDA became aware of the accidents in Panama, it sent its examiners to inspect Multidata. The FDA found that Multidata had received at least six complaints about "calculation errors related to the failure of the firms radiation treatment planning software to correctly handle certain types of blocks (polygons)."

The report said: "As of 6/1/01, there was no documentation that any complaint or incident report analysis had been performed, or corrective action developed or implemented [by Multidata]. In addition, the firm had been aware of this failure since at least 9/92."

Separately, the NRC published the findings of the IAEA in an Information Notice to operators of radiotherapy machines dated Nov. 20, 2001. The notice said: "Specifically, the staff modified its procedures and entered data for multiple shielding blocks together (digitized the blocks), as if they were a single block. The data were accepted by the treatment planning system, but the [Multidata] software calculated incorrect treatment times. Using incorrect treatment times resulted in significant radiation overexposure to patients."


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Next Page: Multidata repeatedly taken to task by the FDA.


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